Comparative Performance of a Vaginal Yeast Test

Comparative Performance of the SavvyCheck Vaginal Yeast Test Versus Culture

The purpose of this study is to establish lay user performance criteria for the SavvyCheck Vaginal Yeast Test in comparison to standard vaginal yeast culture and identification method for Candida (the Reference Method). Polymerase chain reaction (PCR) and sequencing of fungi will be used as an aid to explain the nature of the discrepancy in the case of discordant results between the lay user-performed SavvyCheck Vaginal Yeast Test and standard vaginal yeast culture and identification method for Candida.

Study Overview

• Status: Not yet recruiting
• Conditions: Vulvovaginal Candidiasis
• Intervention / Treatment: Device: SavvyCheck Vaginal Yeast Test (rapid, point-of-care diagnostic test)

Detailed Description

The purpose of this study is to establish lay user performance criteria for the SavvyCheck Vaginal Yeast Test in comparison to standard vaginal yeast culture and identification method for Candida (the Reference Method). Polymerase chain reaction (PCR) and sequencing of fungi will be used as an aid to explain the nature of the discrepancy in the case of discordant results between the lay user-performed SavvyCheck Vaginal Yeast Test and standard vaginal yeast culture and identification method for Candida.

Primary Objective:

The primary objective is to establish lay user performance criteria (sensitivity and specificity) of the SavvyCheck Vaginal Yeast Test in comparison to the Reference Method (vaginal Candida yeast culture)

Secondary Objectives:

1. To determine the positive predictive value and negative predictive value of the lay user-performed SavvyCheck Vaginal Yeast Test in comparison to the Reference Method (vaginal Candida yeast culture)
2. To determine the concordance between the results determined by lay user-performed SavvyCheck Vaginal Yeast Test -vs. trained user-performed SavvyCheck Vaginal Yeast Test

Exploratory Objectives:

1. To determine the concordance between the results determined by lay user-performed SavvyCheck Vaginal Yeast Test -vs. vaginal wet mount microscopy results
2. To determine the concordance between results determined by lay user-performed SavvyCheck Vaginal Yeast Test -vs. PCR and sequencing
3. To determine the concordance between results determined by the Reference Method (vaginal Candida yeast culture) -vs. PCR and sequencing

Primary Endpoints:

Calculation of sensitivity and specificity of the lay user-performed SavvyCheck Vaginal Yeast Test as compared to the Reference Method (vaginal Candida yeast culture)

Secondary Endpoints:

1. Calculation of positive and negative predictive value of lay user-performed SavvyCheck Vaginal Yeast Test results as compared to the Reference Method (vaginal Candida yeast culture)
2. Calculation of concordance between the results determined by lay user-performed SavvyCheck Vaginal Yeast Test results -vs. trained user-performed SavvyCheck Vaginal Yeast Test results

Exploratory Endpoints:

1. Calculation of concordance between the results determined by lay user-performed SavvyCheck Vaginal Yeast Test -vs. vaginal wet mount microscopy
2. Calculation of concordance between results determined by lay user-performed SavvyCheck Vaginal Yeast Test -vs. PCR and sequencing
3. Calculation of concordance between results determined by the Reference Method (vaginal Candida yeast culture) -vs. PCR and sequencing

Women, aged 18 years and older, symptomatic and asymptomatic for vaginitis will be enrolled in the study. We estimate that it will require a total enrollment of up to 600 symptomatic women at all four clinical sites combined, to achieve the target of at least n=216 Reference Method (vaginal Candida yeast culture) positives. In addition, a combined total of 320 asymptomatic women will be enrolled in the study from the four clinical sites combined, to achieve the target of at least n=170 Reference Method (vaginal Candida yeast culture) negatives.

Four, large, regional, DoD military treatment facilities (MTFs) representing two branches of the U.S. military:

1. Womack Army Medical Center (WAMC) at Fort Bragg; Fayetteville, NC
2. Naval Medical Center San Diego (NMCSD); San Diego, CA
3. Naval Medical Center Portsmouth (NMCP); Portsmouth, VA
4. Landstuhl Regional Medical Center (LRMC); Landstuhl, Germany

The SavvyCheck Vaginal Yeast Test is a lateral flow immunochromatographic qualitative test for the detection of Candida antigen in vaginal secretions sampled by a swab, as an aid for identification of vulvovaginal candidiasis as a primary cause of vaginal yeast infections. The SavvyCheck Vaginal Yeast Test is designed for use by women experiencing vaginal symptoms, including: increased vaginal discharge, vaginal itching, vaginal soreness and irritation, rash on the labia, and genital burning that may worsen during urination. The SavvyCheck Vaginal Yeast Test is indicated for over-the-counter use.

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: Elizabeth A Kostas-Polston, PhD; Phone Number: 301.295.1531; Email: elizabeth.kostas-polston@usuhs.edu
• Study Contact Backup: Name: Mary B Engler, PhD; Phone Number: 301.295.3427; Email: mary.engler@usuhs.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women, aged 18 years and older, symptomatic and asymptomatic for vaginitis will be enrolled in the study. We estimate that it will require a total enrollment of up to 600 symptomatic women at all four clinical sites combined, to achieve the target of at least n=216 Reference Method (vaginal Candida yeast culture) positives. In addition, a combined total of 320 asymptomatic women will be enrolled in the study from the four clinical sites combined, to achieve the target of at least n=170 Reference Method (vaginal Candida yeast culture) negatives.

Description

Inclusion Criteria:

Symptomatic Women Symptomatic women include those women who present with a complaint consistent with symptoms of vaginitis (e.g., increased vaginal discharge, vaginal itching, vaginal soreness and irritation, rash on the labia, and genital burning that may worsen during urination). Enrollment will continue at each clinical site until our target number of 216 Reference Method (vaginal Candida yeast culture) positives have been collected. We estimate up to 600 symptomatic women will be enrolled to meet our target.

Inclusion Criteria for Symptomatic Women

1. DoD Military Health System beneficiary
2. Have a healthcare appointment at a recruitment clinic
3. 18 years of age or older
4. Must speak and understand English
5. Able to provide informed consent
6. Women experiencing vaginal symptoms, including: increased discharge, itching, soreness and irritation, rash on the labia, and genital burning that may worsen during urination
7. Must determine the test is applicable to her based on her symptoms after she has read the outside device labeling (box label)

Asymptomatic Women Asymptomatic women include those women who do not present with a complaint consistent with vaginitis. Enrollment will continue at each clinical site until our target number of 170 Reference Method (vaginal Candida yeast culture) negatives have been collected. We estimate up to 320 asymptomatic women will be enrolled to meet our target.

Inclusion Criteria for Asymptomatic Women:

1. DoD Military Health System beneficiary
2. Have a healthcare appointment at a recruitment clinic
3. 18 years of age or older
4. Must speak and understand English
5. Able to provide informed consent
6. Healthy women appearing for routine care without symptoms of vaginal yeast infection

Exclusion Criteria:

If any of the following criteria are met, a potential subject will be excluded from the study:

1. Currently pregnant
2. Currently menstruating
3. History of sexual violence victimization
4. History of any clinical therapies and/or interventions related to gender confirmation (transgender person)
5. Use of any vaginal medication, taken by mouth or vaginally, within the last 7 days
6. Use of any vaginal product within 24 hours, including contraception (cream, gel, or foam), or douching solutions NOTE: Women who currently have an intrauterine device (IUD) placed are eligible to participate

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Symptomatic for vaginal yeast; Women presenting to the clinic with symptoms of vulvovaginal candidiasis.	Device: SavvyCheck Vaginal Yeast Test (rapid, point-of-care diagnostic test); The SavvyCheck Vaginal Yeast Test is a lateral flow immunochromatographic qualitative test for detection of Candida antigen in vaginal secretions, sampled by a swab as an aid for identification of vulvovaginal candidiasis (VVC), as a primary cause of vaginal yeast infections. The SavvyCheck Vaginal Yeast Test is designed for use by women experiencing vaginal symptoms, including: increased vaginal discharge, vaginal itching, vaginal soreness and irritation, rash on the labia, and genital burning that may worsen during urination. The SavvyCheck Vaginal Yeast Test is indicated for OTC use.
Asymptomatic for vaginal yeast; Women presenting to the clinic with no symptoms of vulvovaginal candidiasis.	Device: SavvyCheck Vaginal Yeast Test (rapid, point-of-care diagnostic test); The SavvyCheck Vaginal Yeast Test is a lateral flow immunochromatographic qualitative test for detection of Candida antigen in vaginal secretions, sampled by a swab as an aid for identification of vulvovaginal candidiasis (VVC), as a primary cause of vaginal yeast infections. The SavvyCheck Vaginal Yeast Test is designed for use by women experiencing vaginal symptoms, including: increased vaginal discharge, vaginal itching, vaginal soreness and irritation, rash on the labia, and genital burning that may worsen during urination. The SavvyCheck Vaginal Yeast Test is indicated for OTC use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess sensitivity and specificity between lay user-performed SavvyCheck Vaginal Yeast Test result compared to the Reference Method (vaginal Candida yeast culture)	Calculation of sensitivity and specificity of the lay user-performed SavvyCheck Vaginal Yeast Test as compared to the Reference Method (vaginal Candida yeast culture)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess positive and negative predictive values of the lay-user SavvyCheck Vaginal Yeast Test result as compared to the Reference Method (vaginal Candida yeast culture)	Calculation of the positive and negative predictive values of lay user-performed SavvyCheck Vaginal Yeast Test results as compared to the Reference Method (vaginal Candida yeast culture).	12 months
Assess concordance between the lay user-performed SavvyCheck Vaginal Yeast test result and the trained user-performed result.	Calculation of concordance between the lay use-performed and the trained user-performed SavvyCheck Vaginal Yeast test results.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess concordance between the lay user-performed SavvyCheck Vaginal Yeast test result -vs vaginal wet mount microscopy	Calculation of concordance between the results between the lay user-performed SavvyCheck Vaginal Yeast Test -vs. vaginal wet mount microscopy	12 months
Assess concordance between the lay user-performed SavvyCheck Vaginal Yeast test result -vs. PCR and sequencing	Calculation of concordance between the results between the lay user-performed SavvyCheck Vaginal Yeast Test -vs. PCR and sequencing	12 months
Assess concordance between the Reference Method results (vaginal yeast culture) -vs PCR and sequencing	Calculation of concordance between the Reference Method (vaginal yeast culture) results -vs PCR and sequencing	12 months

Collaborators and Investigators

• Sponsor: Uniformed Services University of the Health Sciences
• Collaborators: Savvyon Diagnostics Ltd.
• Investigators: Principal Investigator: Elizabeth A Kostas-Polston, PhD, Uniformed Services University of the Health Sciences

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 15, 2021
• Primary Completion (ANTICIPATED): November 30, 2022
• Study Completion (ANTICIPATED): November 30, 2022

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (ACTUAL): October 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Vaginal candidiasis, Vaginal yeast culture
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Candidiasis; Candidiasis, Vulvovaginal
• Other Study ID Numbers: USUHS.2020-058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No